Manager I, Eu Labeling Management

Bristol Myers Squibb

Warsaw, Poland
Base: zł173,780 - zł210,584; bonus/equity: + incen...
Hybrid (50% onsite)
Eu regulatory labelling requirements knowledge
Ema submission document preparation
Artwork creation and approval coordination
Bristol Myers Squibb is seeking a Manager I for EU Labeling Management in Warsaw, Poland. The role involves overseeing EU labeling processes, ensuring compliance with regulatory standards, and managing project activities while fostering a collaborative team environment

Job Summary

  • The role involves providing EU labelling process oversight and project management from submission planning to post-approval activities.
  • Candidates must ensure high quality and accuracy of all labelling documents while coordinating translations and artwork updates across multiple languages.
  • Bristol Myers Squibb offers a wide variety of competitive benefits and programs to support employee goals both at work and in personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Manager I for EU Labeling Management in Warsaw, Poland. The role involves overseeing EU labeling processes, ensuring compliance with regulatory standards, and managing project activities while fostering a collaborative team environment.

Salary

Base: zł173,780 - zł210,584; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs provided

Skills & Requirements

Must-have

  • EU regulatory labelling requirements knowledge
  • EMA submission document preparation
  • Artwork creation and approval coordination
  • Translation project management for PI
  • Quality control of language PIs

Nice-to-have

  • Mentoring junior staff capabilities
  • Knowledge of biopharma manufacturing complexities
  • Experience with readability testing processes
  • Strong communication and organizational skills
  • Proficiency in Microsoft Office Suite

Key Requirements

  • Degree preferred in science
  • 3 years' experience in Pharmaceutical industry
  • Direct regulatory or labelling experience in regulated environment
  • Excellent command of English language
  • Solid understanding of EMA Regulatory and Labelling regulations

Work Rights

Not specified

Tailored Resume

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